Stroke, Upper Extremity Hemiparesis
Conditions
Brief summary
This study will compare bilateral priming followed by task specific training to health care education followed by the same task specific training protocol. The intention is to understand the effects of priming on upper limb training post-stroke.
Detailed description
Techniques to enhance use dependent plasticity have been examined in stroke rehabilitation research. The purpose of these techniques is to prime the cortex prior to training. The priming techniques previously described in the literature include medication (i.e. amphetamines), transcranial electric or magnetic stimulation, and manipulation of somatosensory input. Here, the investigators examine a priming technique which is non-invasive and free of side effects. The technique described in this study uses bilateral, symmetrical, rhythmic movement bilateral priming and its purpose is to ready the motor cortex for functional limb training. A rocker is used so that the less affected limb can drive the affected one in symmetrical wrist flexion and extension. In this project, the investigators intend to compare bilateral upper limb priming with task specfiic training to a health care education website program followed by the same task specific training as the experimental group.This active comparator (health care education) will receive stroke related health education via a website from the American Heart Association. Transcranial Magnetic Stimulation willl include measurement of transcallosal inhibition persistence from the affected hemisphere to the less affected hemisphere and vice versa ( less affected to affected). The investigators expect the bilateral priming group to have greater changes in transcranial magnetic stimulation measures and greater improvements in behavioral measures at all time points.
Interventions
BEHAVIORALpriming and task specific training
This task specific training protocol has been used in several clinical trials.
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must have survived a unilateral stroke at least six months prior to enrollment * Fugl Meyer Upper Extremity Score between 22-38.
Exclusion criteria
* No individuals who have a pacemaker, metal implant in head or neck, history of seizures, recent concussion or history of headaches
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change Score of Chedoke Arm and Hand Activity Index Nine (CAHAI 9) Baseline to Follow-up (2 Timepoints) | value at 6 weeks minus value at baseline | The change score (Follow-up - Baseline) for the Chedoke Arm and Hand Activity Index 9 is reported. The change score scale ranges 0(min) to 63 (max). Higher scores indicate greater ability. Follow-up is at 6 weeks post treatment cessation. The scale measure bilateral activity performance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change Score (Value at Follow-up - Value at Baseline) Fugl Meyer Upper Extremity Test of Function | value at 6 weeks minus value at baseline | Change score between 2-time points (6 weeks follow up - baseline) Change score scale: minimum is 0 and maximum is 66. Higher scores indicate better outcomes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bilateral Priming Bilateral priming a priming technique which is non-invasive and free of side effects. The technique described in this study uses bilateral, symmetrical, rhythmic movement bilateral priming and its purpose is to ready the motor cortex for functional limb training. A rocker is used so that the less affected limb can drive the affected one in symmetrical wrist flexion and extension. The priming (15 minutes) will be following by task specific training (45 minutes). Subjects will then have a break (betw. 30-60 minutes) and then repeat the above. Total priming for one day is 30 minutes. Total task specific training for one day is 90 minutes
priming and task specific training: This task specific training protocol has been used in several clinical trials. | 8 |
| Health Education The group with no priming will receive stroke related health education via a website from the American Heart Association (15 minutes). They will use their affected hand (as they are able) This will be followed by 45 minutes of the same task specific arm training protocol described in the bilateral priming group. This group will follow the same schedule as above. The health education (15 minutes) will be following by task specific training (45 minutes). Subjects will then have a break (betw. 30-60 minutes) and then repeat the above. Total time on health education website for one day is 30 minutes. Total task specific training for one day is 90 minutes
priming and task specific training: This task specific training protocol has been used in several clinical trials. | 8 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Bilateral Priming | Health Education | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 3 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 5 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 8 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 6 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 1 Participants | 4 Participants |
| Region of Enrollment United States | 8 participants | 8 participants | 16 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 1 / 8 | 0 / 8 |
Outcome results
Primary
Change Score of Chedoke Arm and Hand Activity Index Nine (CAHAI 9) Baseline to Follow-up (2 Timepoints)
The change score (Follow-up - Baseline) for the Chedoke Arm and Hand Activity Index 9 is reported. The change score scale ranges 0(min) to 63 (max). Higher scores indicate greater ability. Follow-up is at 6 weeks post treatment cessation. The scale measure bilateral activity performance.
Time frame: value at 6 weeks minus value at baseline
Population: individuals who have survived a stroke greater than 6 months prior to enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bilateral Priming | Change Score of Chedoke Arm and Hand Activity Index Nine (CAHAI 9) Baseline to Follow-up (2 Timepoints) | 6.69 score on a scale | Standard Deviation 1.2 |
| Health Education | Change Score of Chedoke Arm and Hand Activity Index Nine (CAHAI 9) Baseline to Follow-up (2 Timepoints) | 5.03 score on a scale | Standard Deviation 1.8 |
Secondary
Change Score (Value at Follow-up - Value at Baseline) Fugl Meyer Upper Extremity Test of Function
Change score between 2-time points (6 weeks follow up - baseline) Change score scale: minimum is 0 and maximum is 66. Higher scores indicate better outcomes.
Time frame: value at 6 weeks minus value at baseline
Population: individuals who have survived a stroke greater than 6 months prior to enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bilateral Priming | Change Score (Value at Follow-up - Value at Baseline) Fugl Meyer Upper Extremity Test of Function | 10 units on a scale | Standard Error 2.5 |
| Health Education | Change Score (Value at Follow-up - Value at Baseline) Fugl Meyer Upper Extremity Test of Function | 4.3 units on a scale | Standard Error 1.67 |